Zimmer Patient Specific Instrument PERSONA CR Pin recall
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the…
Why was Zimmer Patient Specific Instrument PERSONA CR Pin recalled?
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
- Product
- Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the…
- Recalling firm
- Materialise USA LLC
- Quantity
- 1
- Distribution
- Nationwide Distribution to MN only
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)